Personalized Neuromodulation System Receives FDA Clearance for PTSD Treatment

Post-traumatic stress disorder (PTSD) is a trauma-related mental health condition marked by persistent reexperiencing, hyperarousal, and avoidance that can impair daily functioning. Many patients, including veterans—among whom approximately 17.5 people die by suicide each day—do not achieve remission with talk therapy or selective serotonin reuptake inhibitor (SSRI) medications. Health systems need options that are effective and tolerable for patients who struggle to complete psychotherapy or respond to drugs. To help address this challenge, investigators have developed a personalized neuromodulation approach that has now received U.S. Food and Drug Administration (FDA) clearance.

The Magnetic e-Resonance Therapy (MeRT) system from Wave Neuroscience, created in collaboration with the Texas A&M Health Institute of Biosciences and Technology, has been cleared to map and treat brain regions implicated in PTSD. The platform identifies the cortical areas most affected by the disorder and directs stimulation to those targets. Early findings are being prepared for public dissemination, with program leaders reporting encouraging clinical improvements.

MeRT integrates electroencephalography (EEG) to characterize each patient’s brain activity with transcranial magnetic stimulation (TMS) delivered via a scalp coil. An AI-derived multivariate algorithm then personalizes stimulation parameters to the individual’s neurophysiologic profile. This patient-specific approach is designed to move beyond conventional, protocolized TMS by focusing treatment on the circuits most disrupted in PTSD.

In the clinical program, participants underwent five treatment sessions per week for five to six weeks. Reported benefits appeared to persist beyond the end of therapy. The study’s lead psychiatrist was from the Texas A&M Naresh K. Vashisht College of Medicine.

Regulatory progress began in 2024, when the MeRT platform received FDA Breakthrough Device designation, providing an expedited review pathway while maintaining strict scientific standards. The effort advanced from launch to clearance in just over two years, a rapid timeline for a medical device trial. The partners are now engaging stakeholders to broaden access, support insurance coverage, and explore potential applications beyond PTSD.

“In comparison to that study, our FDA trial reported a 52% reduction in symptoms, so more than a four-fold increase in efficacy. And more importantly, we saw 68% remission in our clinical trial. So, it’s really a quantum change, an inflection point in what we can offer to patients. From a clinical care perspective, that’s really meaningful,” said Erik Won, DO, chief medical officer at Wave Neuroscience.

“Right now, the FDA has approved only two medications for PTSD. It doesn’t mean that only two of them are used, but both are SSRIs. This is the first time that in addition to the medication, we have a non-medication option. There is psychotherapy that people use for PTSD, but psychotherapies require a lot of effort. People must participate actively, and many drop out because it’s too anxiety provoking. So now we have a unique alternative,” said Israel Liberzon, M.D., distinguished professor in psychiatry and behavioral sciences at the Texas A&M Naresh K. Vashisht College of Medicine.

Related Links
Texas A&M Health Institute of Biosciences and Technology
Wave Neuroscience